NCT05605574

Longitudinal Early Advance Care Planning Discussions and Documentation (LEADD) Program: An Exploratory Study in Adolescents and Young Adults (AYAs) Receiving Hematopoietic Stem Cell Transplant

Extracted Fields (from Registry)
Protocol IDNCT05605574
Registration Date2022-11-04
Statusrecruiting
SponsorNational Cancer Institute (NCI)
CountryUnited States
Industrynot industry
Blindingunblinded
Center Typemulticenter RCT
Scopenational RCT
First Patient In2022-11-16
Last Patient Out2026-12-31
Publicationn
Gender %ALL
Mean Age18 Years - 120 Years
LLM Classifications (Side-by-Side)
Field OPENAI
gpt-4o
Thinking: o3
3439ms / 9760 tok
GLM
glm-5.1
7718ms / 9938 tok
CLAUDE
claude-sonnet-4-20250514
Thinking: claude-opus-4-20250514
5291ms / 11365 tok
Review
rct_type N/A N/A N/A OK
cancer_status Cancer Cancer Cancer OK
non_cancer_spec N/A N/A N/A OK
setting_patient inpatient mixed → inpatient
shaky reasoning
✓ Unanimous Initial: mixed Requery: inpatient — The study involves patients undergoing allogeneic hematopoietic stem cell transplantation, a procedure that typically requires hospitalization.
inpatient inpatient inpatient → inpatient
shaky reasoning
✓ Unanimous Initial: inpatient Requery: inpatient — Patients are undergoing hematopoietic stem cell transplantation (HSCT) which requires hospitalization and continuous monitoring during the treatment period.
OK
setting_place hospital hospital hospital OK
feasibility feasibility RCT feasibility RCT feasibility RCT OK
intervention_pharmacologic no no no OK
intervention_chemo_immuno_radio no no no OK
intervention_complementary no no no OK
intervention_device no no no OK
intervention_psychological no no no OK
intervention_complex no no no OK
intervention_acp yes yes yes OK
intervention_music no no no OK
intervention_screening no no no OK
intervention_palliative yes yes → yes → yes
shaky reasoning
✗ No consensus Initial: yes Requery: yes — The study involves a SUPPORTIVE_CARE purpose with advance care planning discussions related to patient-centered care, which aligns with palliative care services. Thinking: yes — The intervention consists of advance care planning conversations as a supportive-care communication program, which constitutes a palliative care service rather than a pharmacologic or disease-directed treatment.
yes no no → yes → no
shaky reasoning
✗ No consensus Initial: no Requery: yes — The intervention is advance care planning (ACP) conversations and documentation, which is a core component of palliative care service delivery focused on goals of care discussions and care planning. Thinking: no — The intervention being tested is advance care planning (ACP) conversations using structured guides, not palliative care consultation, referral, or service delivery itself.
intervention_education yes yes → yes → yes
shaky reasoning
✗ No consensus Initial: yes Requery: yes — The primary component of the trial involves guided discussions and education about advance care planning, which is an educational intervention for patients and caregivers. Thinking: yes — The main intervention is a series of structured conversations that teach and guide patients/caregivers through advance care-planning materials, making patient/caregiver education the primary focus.
no no no → yes → no
shaky reasoning
✗ No consensus Initial: no Requery: yes — The intervention consists of structured educational conversations teaching patients and caregivers about advance care planning topics and guiding them through completing the Voicing My CHOiCES advance care planning document, which is primarily educational in nature. Thinking: no — The intervention primarily consists of facilitated advance care planning conversations to elicit and document patient values and preferences, not educational or training programs.
intervention_digital no no no OK
intervention_other no no no OK
outcome_symptom no no no OK
outcome_qol no no no OK
outcome_dignity no no no OK
outcome_cost no no no OK
outcome_other yes yes yes OK
pharmacologic_sub N/A N/A N/A OK
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